Clinical Study Protocol and Investigator’s Brochure Development

This course outlines the medical and regulatory aspects of clinical research procedures and SOP development. The support functions of clinical research and regulatory affairs department (including adverse events reporting, literature reviews, post-marketing surveillance, and summary of product characteristics, label changes, advertising, patient information and safety reporting) are examined and evaluated.

Upon completion of this course, the student will demonstrate basic cognitive and practical knowledge and skills for discussing the scientific approach taken in the development of a research protocol, in identifying the key elements that must be addressed in a research protocol, to differentiate between the various types of research designs and concepts, including the protocol elements used in each design, and to discuss the ethical considerations and issues related to the development of research protocols.

This course is intended primarily for students wishing to pursue a career in the pharmaceutical industry, in Clinical Research, Drug Safety, and Pharmacovigilance.